triclabendazole Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anthelminthics, tiabendazole derivatives 2734 68786-66-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • egaten
  • triclabendazole
  • fasinex
Benzimidazole antiplatyhelmintic agent that is used for the treatment of FASCIOLIASIS and PARAGONIMIASIS.
  • Molecular weight: 359.65
  • Formula: C14H9Cl3N2OS
  • CLOGP: 6.44
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 1
  • TPSA: 37.91
  • ALOGS: -5.85
  • ROTB: 3

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI

Approvals:

DateAgencyCompanyOrphan
Feb. 13, 2019 FDA NOVARTIS PHARMS CORP
Jan. 1, 1990 YEAR INTRODUCED

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC P02BX04 ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS
ANTHELMINTICS
ANTITREMATODALS
Other antitrematodal agents
MeSH PA D000871 Anthelmintics
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000977 Antiparasitic Agents
MeSH PA D000980 Antiplatyhelmintic Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Infection by Fasciola indication 111922007 DOID:885

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.08 acidic
pKa2 3.81 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
250MG EGATEN NOVARTIS N208711 Feb. 13, 2019 RX TABLET ORAL Feb. 13, 2024 NEW CHEMICAL ENTITY
250MG EGATEN NOVARTIS N208711 Feb. 13, 2019 RX TABLET ORAL Feb. 13, 2026 INDICATED FOR THE TREATMENT OF FASCIOLIASIS IN PATIENTS 6 YEARS OF AGE AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Fasciola species Parasite OTHER DRUG LABEL DRUG LABEL
Cruzipain Enzyme IC50 4.82 CHEMBL

External reference:

IDSource
D07364 KEGG_DRUG
4038425 VANDF
C4704786 UMLSCUI
CHEBI:94759 CHEBI
CHEMBL1086440 ChEMBL_ID
D000077682 MESH_DESCRIPTOR_UI
50248 PUBCHEM_CID
5003 INN_ID
DB12245 DRUGBANK_ID
4784C8E03O UNII
2118525 RXNORM
23285 MMSL
d06607 MMSL
010991 NDDF
713429009 SNOMEDCT_US
714020008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
EGATEN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0937 TABLET 250 mg ORAL NDA 29 sections